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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 03/21/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving dilaudid (. 8 mg at. 40201 mg/day) and bupivacaine (30 at 5. 07525 mg/day) via an implantable pump for unknown indications for use. It was reported that the patient had a reaction following a catheter dye study. It was reported that the patient 'felt like she was sitting on a hot plate and was perspiring from her mid back to gluteus'. The reaction resolved within 3-4 hours. It was noted that the catheter was unable to be aspirated due to an occlusion. A pump replacement secondary to normal battery depletion was planned and the catheter would be replaced then.
 
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath , product type: catheter. Other relevant device(s) are: if information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14166710
MDR Text Key289737363
Report Number3004209178-2022-05046
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
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